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NCT Number: NCT06447272

Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke

This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 40 and 80 years;
  • breathing spontaneously;
  • clinically diagnosed with ischemic and/or haemorrhagic stroke;
  • stroke duration from onset between 1 and 12 months;
  • no history of thoracic or abdominal surgery within the last 6 months;
  • able to understand and follow verbal instructions;
  • no facial palsy, or mild facial palsy without limitation of labial occlusion;
  • capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
  • no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 26;
  • able to independently walk at least 10 meters with or without an assistive device.

Exclusion criteria

  • acute myocardial infarction or acute heart failure;
  • acute pain in any part of the body;
  • with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention;
  • with chronic cardiovascular dysfunction;
  • Trunk Impairment Scale (TIS) score ≥ 20;
  • presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.

Treatment and study plan

Sham inspiratory muscle training

Other

This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)

target inspiratory muscle training

Other

This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).

Primary outcomes

  1. Diaphragmatic thickness

    Time frame: baseline, after 4 weeks of intervention

    The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: baseline, after 4 weeks of intervention

    Forced Vital Capacity (FVC) is a measurement used in pulmonary function tests to assess lung function. It refers to the total volume of air that a person can forcibly exhale from their lungs after taking the deepest breath possible. It will be measured using the spirometer.

  2. Forced Expiratory Volume in one second (FEV1)

    Time frame: baseline, after 4 weeks of intervention

    Forced Expiratory Volume in one second (FEV1) measures the volume of air a person can forcibly exhale in the first second of a forced breath. It will be measured using the spirometer.

  3. Maximum Inspiratory Pressure (MIP)

    Time frame: baseline, after 4 weeks of intervention

    Maximum Inspiratory Pressure (MIP) is a measure used in pulmonary function testing to assess the strength of the respiratory muscles, particularly the muscles used for inhalation. It will be measured using the spirometer.

  4. Trunk Impairment Scale (TIS)

    Time frame: baseline, after 4 weeks of intervention

    The TIS is a rating scale used to measure static sitting balance, dynamic sitting balance, and trunk coordination. The total TIS score ranges from 0 to 23 points, with a higher score indicating better trunk function.

  5. Sitting Balance

    Time frame: baseline, after 4 weeks of intervention

    A force plate will be used to measure changes in the center of pressure during the performance of various tasks in sitting positions.

  6. Timed Up and Go Test (TUG)

    Time frame: baseline, after 4 weeks of intervention

    TUG is a test to measure the time that a participant needs to stand up from a standard armchair, walk a short distance of about 3 meters, turn around, walk back to the chair, and sit down again.

  7. Falls efficacy scale international

    Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention

    The Falls Efficacy Scale-International (FES-I) is a questionnaire measuring fear of falling in older adults. It consists of 16 items, each scored from 1 to 4, with higher scores indicating greater fear. The total score ranges from 16 (lowest fear) to 64 (highest fear). It is used in clinical settings to assess fall risk and tailor interventions.

  8. 6-Minute Walk Test

    Time frame: baseline, after 4 weeks of intervention

    The 6-Minute Walk Test (6MWT) measures how far someone can walk in six minutes. It assesses exercise capacity and mobility.

  9. Stroke Impact Scale

    Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention

    The Chinese version of the Stroke Impact Scale 3.0 (SIS) will be used to measure the quality of life. Scores range from 0 to 100, a higher overall score suggests better physical, emotional, and social functioning, while a lower score may indicate more significant impairment or limitations.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang LIU

CONTACT

[email protected]

+8613603049475

William Wai Nam Tsang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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